Cleared Traditional

K180286 - Polyethylene Catheter

K180286 is the FDA 510(k) clearance for Polyethylene Catheter by Cook Incorporated. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K180286 · Cook Incorporated · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2018
Decision
267d
Days
Class 2
Risk

K180286 is an FDA 510(k) clearance for the Polyethylene Catheter. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on October 26, 2018 after a review of 267 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook Incorporated devices

Submission Details

510(k) Number K180286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2018
Decision Date October 26, 2018
Days to Decision 267 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 125d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 290
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K180286.
Polyethylene Catheter
K181722 · Cook Incorporated · Mar 2019
Arterial Pressure Monitoring Set/Tray
K180846 · Cook Incorporated · Dec 2018
Arterial Pressure Monitoring Set/Tray
K180792 · Cook Incorporated · Nov 2018
Royal Flush Plus High-Flow Catheter
K180054 · Cook Incorporated · Oct 2018
4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters
K181836 · Cordis, A Cardinal Health Company · Aug 2018
AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters
K173762 · AngioDynamics, Inc. · Jul 2018